PopVax
Website:
popvax.com
Job details:
We are seeking a detail-oriented and proactive professional to join our
Production – Quality Management team. As a member, you will play a key role in maintaining high standards of documentation and quality systems in a cGMP-regulated environment. We are not only looking for people comfortable working in the GMP framework, but who can translate any R&D product to the safety and quality levels that cGMP would require.
This is a unique opportunity to work at the forefront of biologics manufacturing, with a focus on vaccines, nucleic acid-based products, and advanced delivery systems. Aside from vaccines, we have made substantial progress applying AI and high-throughput functional assays to the development of personalized generative medicines for cancer immunotherapy against hard-to-treat solid tumours such as liver cancer and pancreatic cancer, which kill >80% of patients within 5 years of diagnosis.
As frontier AI models begin to demonstrate capabilities that might enable prospective bioterrorists with no scientific background to design and produce novel viruses and bacteria as bioweapons, our full-stack approach to machine learning-enabled vaccine development at high speed is the foundation upon which we are building rapid response capabilities for the design and distributed manufacture of vaccines and anti-infectives against de novo pathogens to fortify global biosecurity.
We believe it is imperative that we have indigenous next-generation pharmaceutical technologies – our own research and development, not merely the means of production – in India and the rest of the developing world. It is a surprisingly little-known fact that despite India’s much-vaunted manufacturing capabilities, Indian pharma and biotech companies do almost no original research, choosing instead to pursue generics and biosimilars which, though lower in profit margin than original products, have a far lower failure rate and do not require expensive large-scale clinical trials to prove efficacy. Even when it comes to vaccines, where India is widely considered a global leader, our companies either use very old technology, produce copies of innovator vaccines once patents expire, or, in a few cases, licence products from Western companies and universities. While these companies have contributed massively to global public health by lowering the cost and increasing the supply of essential pharmaceutical products, they do not possess the capabilities or inclination to develop entirely new vaccines and therapeutics from scratch.
So, if you are someone who is wanting to expand their horizons, learn, plan and manage such first-of-its-kind projects, this job is for you.
The Candidate Should Possess
- A master’s or bachelor’s degree in pharmaceutical sciences, biology, biotechnology, or another life sciences field.
- Proficiency in communicating and drafting documents such as SOPs, QMS documentation, protocols, and reports in formal English.
- Sound understanding of applied mathematical skills, including basic statistical analysis.
- Expertise in Google Workspace, specifically formula-enabled sheets and MS Office.
- A proactive learning attitude with high attention to detail.
- Ability to manage multiple documentation tasks accurately and efficiently.
The Ideal Candidate Will Possess
- Documentation experience in a cGMP environment within vaccines or other biologics is preferred. Specific experience with nucleic acid or nanoparticle-based products would be a significant advantage.
- In-depth understanding of cGMP requirements and regulations, along with the core principles underlying them. Experience in drafting GMP SOPs, batch manufacturing records (BMRs), production reports, and other related documents.
- Strong knowledge of pharmaceutical QMS principles, with direct experience in handling and documenting deviations, change control, CAPA, OOS, and OOT investigations.
Role Responsibilities
- Not just oversee the regular qualification and maintenance of Production facility and equipment, but maintain a complete calendar of all events and tasks related to the Production facility equipment, such that you don’t ask the people, but people ask you what’s next?
- Not just coordinate with QA, QC and Engineering, but act as a glue and make them work in time, prevent non-compliances and make it better.
- Have complete control over the maintenance of GMP- bill of materials (BOM) for the housekeeping activities and batch related activities, such that we are never out of materials and are informed of any shortcomings at least 6 weeks before.
- Be a resourceful person who can present data or answer any random question related to Production activity within 30 seconds of management asking you.
- Manage the staff allotted to you for regular and extraordinary activities which may require your ground presence at any time in the clock and calendar.
- Handle not just document passing, but have a total understanding of whatever needs to be done, recorded and maintained and use that information to continually improve systems, without prompting.
- Have zero fear of seniority and ask the right questions at the right times, become an equal owner of the facility and not limit yourself to “your domain”, but do whatever it takes to uphold the facility and product at its best quality.
- Never leave a question hanging. "I don't know" is a perfectly good first half of a sentence; it is never the whole sentence. The expectation is that you say what you don't yet know, then go and find the documented answer and close the loop — quickly, and without needing to be chased.
- Never sits idle and always looks for ways to improve both professional self, cGMP practices and PopVax as a whole.
- Strong aptitude in knowing the science behind all the products and projects ongoing at PopVax, such that they can be inducted into the GMP facility seamlessly without delays.
- Willing to learn and handle risk management for an equipment, process, product or any project.
- Has the ability to stay on top of all things happening and get to the bottom of things.
Click on Apply to know more.
